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In vitro diagnostic medical devices
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Infectious diseases
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Multiple parameters - (infect. immunology/nat)
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Multiple viruses panels
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Multiple viruses - multiplex assays - other
Multiple viruses - multiplex assays - other
W0105070399
105 devices
InfectCheck SARS-CoV-2/RSV/FluA/FluB
Shenzhen Kang Sheng Bao Bio-Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Tigsun Flu A/B, RSV, COVID-19 Ag Combo Test
Beijing Tigsun Diagnostics Co., Ltd.
·
,
China
IVD General
CE/IVDD
Influenza A / B / Parainfluenza virus Antigen Rapid Test Cassette (Colloidal Go…
Beijing Applied Biological Technologies Co., Ltd.
·
,
China
IVD General
CE/IVDD
Tigsun Flu A/B, RSV, COVID-19 Ag Combo Test
Beijing Tigsun Diagnostics Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromat…
Shenzhen Microprofit Biotech Co., Ltd
·
,
China
IVD for self-testing
CE/IVDD
Five Respiratory Pathogens Nucleic Acid Test Kit(PCR-Fluorescent Probe Method)
RocGene (Xuzhou) Technology Limited
·
,
China
IVD General
CE/IVDD
RSV/Adenovirus Antigen Combo Fluorescence Rapid Test Cassette (Swab)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Five Respiratory Virus Nucleic Acid Test Kit (PCR Fluorescent Probe Method)
RocGene (Xuzhou) Technology Limited
·
,
China
IVD General
CE/IVDD
RIDA®Plex Herpes, Enterovirus and Adenovirus 8 well Step 1
AusDiagnostics Pty Ltd
·
,
Australia
IVD Annex II List B
CE/IVDD
SARS-CoV-2/InFluA/InFluB Antigen Rapid Test (Colloidal Gold)
Shenzhen Kang Sheng Bao Bio-Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
RADI FAST Flu-SC2 Detection Kit
KH Medical Co., Ltd.
·
,
South Korea
IVD General
CE/IVDD
RIDA®Plex Viral 12 well Step 1
AusDiagnostics Pty Ltd
·
,
Australia
IVD Annex II List B
CE/IVDD
Influenza A/B Antigen Detection Kit (Immunochromatography)
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-F…
Sansure Biotech Inc.
·
,
China
IVD General
CE/IVDD
Tigsun Flu A/B, RSV, COVID-19 Ag Combo Test
Beijing Tigsun Diagnostics Co., Ltd.
·
,
China
IVD General
CE/IVDD
Step 1 tubes for Herpes, Enterovirus and Adenovirus 8-well
AusDiagnostics Pty Ltd
·
,
Australia
IVD Annex II List B
CE/IVDD
Viral and Syphilis 12-well
AusDiagnostics Pty Ltd
·
,
Australia
IVD Annex II List B
CE/IVDD
Step 2 Plates for Viral CSF (8-well)
AusDiagnostics Pty Ltd
·
,
Australia
IVD Annex II List B
CE/IVDD
Tigsun Flu A/B, COVID-19 Ag Combo Test
Beijing Tigsun Diagnostics Co., Ltd.
·
,
China
IVD General
CE/IVDD
Rotavirus/Adenovirus/Norovirus Antigen Rapid Test Cassette (Colloidal Gold Meth…
Beijing Applied Biological Technologies Co., Ltd.
·
,
China
IVD General
CE/IVDD
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